New Delhi, Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market generic sacubitril and valsartan tablet combination, used to treat chronic heart failure in adults.
The approval by the US Food and Drug Administration (USFDA) is for the marketing of sacubitril and valsartan tablets in strengths of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing.
Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization.
The company said the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.
The approval by the US Food and Drug Administration (USFDA) is for the marketing of sacubitril and valsartan tablets in strengths of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing.
Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization.
The company said the drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad.
